In its announcement, the FDA acknowledged that previous research has been conducted on the topic, which concluded that “simple quantitative information could be conveyed in DTC television ads in ways that increased consumer’s knowledge about the drug.” The previous study only tested consumers’ understanding of simple drug information; and as many people know, drug information can sometimes be extremely complicated. As such, FDA designed two studies that would determine “whether consumers can use more complicated information when assessing prescription drug information in television DTC ads.”

As part of this October 2015 announcement, FDA requested feedback from the public and asked any interested parties to submit comments on the proposed study. FDA received four public comments in response to this request, along with a number of other comments which were not submitted publicly. On Friday, March 18, 2016, the FDA published a notice in the Federal Register which included the additional comments that were submitted as well as the Agency’s responses.

Additional information on the specific comments and the accompanying responses can be found in the Federal Register notice.

The Weinberg Group has significant expertise in working through advertising compliance issues. To discuss this or any other FDA-related matter, contact us today.